Airway Management Clinical Trial
— REDECAPOfficial title:
Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)
NCT number | NCT02512744 |
Other study ID # | 3/7/2015 n67 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2016 |
Est. completion date | May 1, 2018 |
Verified date | August 2018 |
Source | Hospital Virgen de la Salud |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing
two different decannulation protocols:
1. based on capping trials to decide decannulation,
2. based on the aspiration frequency to decide decannulation time. High-flow conditioned
oxygen therapy will be applied to all patients through the tracheal cannula. In patients
included in the suctioning frequency based protocol along the study period and in
patients included in the capping trial protocol along periods out of capping trials.
Status | Completed |
Enrollment | 330 |
Est. completion date | May 1, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected). Exclusion Criteria: - Patients consedered non-decannulable at time of randomization: 1. unconscious patient (motor component of GCS score <6 points). 2. Severe swallowing function (based on drink test). 3. Airway patency problem (based of intolerance of occlusion test). 4. Neuromuscular diseases. 5. Patients with a Sabadell score >2. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Del Mar | Barcelona | |
Spain | Hospital Universitario Vall D´Ebron | Barcelona | |
Spain | Hospital Universitario de Ciudad Real | Ciudad Real | |
Spain | Hospital Universitario Ramon Y Cajal | Madrid | |
Spain | Hospital Virgen de La Salud | Toledo |
Lead Sponsor | Collaborator |
---|---|
Hospital Virgen de la Salud |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decannulation time | Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation | Patients will be followed for the duration of hospital stay, an expected average of 3 months | |
Secondary | Decannulation failure | Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100 | Patients will be followed for the duration of hospital stay, an expected average of 3 months | |
Secondary | Intensive Care Unit Lenght of stay | Time since ICU admission to ICU discharge | Patients will be followed for the duration of ICU stay, an expected average of 2 months | |
Secondary | Hospital lenght of stay | Time since hospital admission to hospital discharge | Patients will be followed for the duration of hospital stay, an expected average of 3 months | |
Secondary | ICU mortality | ICU mortality in every study group | Patients will be followed for the duration of ICU stay, an expected average of 2 months | |
Secondary | Hospital mortality | Hospital mortality in every study group | Patients will be followed for the duration of hospital stay, an expected average of 3 months | |
Secondary | Respiratory infection | Post-randomization pneumonia and tracheobronchitis rate in every study group | Patients will be followed for the duration of hospital stay, an expected average of 3 months |
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